FDA.report

MSI Precision Specialty Instruments

Primary DI
00194613064488
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
5-5112
Device description
Guyton-Park Speculum, Solid 14mm Blades With Dull Finish, 45mm Spread, Suture Posts, Canthus Bar, And Overall Length Of 3 1/4" (82mm)
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNCSpecula, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00194613064488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613064488001946130644881946130644880194613064488

GMDN Terms

TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)935-8181sales@msiprecision.com

Regulatory Flags

DUNS number
556623486
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00194613000264MSI Precision Specialty InstrumentsCA12PK-302025-08-01
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00194613000370MSI Precision Specialty InstrumentsCA19502025-08-01
00194613000394MSI Precision Specialty InstrumentsCA19702025-08-01
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00194613000912MSI Precision Specialty InstrumentsCA24702025-08-01
00194613000943MSI Precision Specialty InstrumentsCA25002025-08-01
00194613000950MSI Precision Specialty InstrumentsCA2500-1.5-902025-08-01

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05056785302988Kratz Plastic Mechanical SpeculumBLINK MEDICAL LIMITEDHNC2026-02-04
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